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Harter M.,University of Hamburg | Kentgens M.,Gesundheitswirtschaft Hamburg GmbH | Brandes A.,Gesundheitswirtschaft Hamburg GmbH | Dirmaier J.,University of Hamburg | And 8 more authors.
European Archives of Psychiatry and Clinical Neuroscience | Year: 2012

With the public-funded research and development project psychenet: the Hamburg Network for Mental Health (2011-2014), the Federal Ministry of Education and Research contributes to strengthening healthcare regions in Germany by establishing new trans-sectoral cooperations and implement and evaluate selected innovations. More than 60 partners from research, health care, health industry and government in the Free and Hanseatic City of Hamburg are promoting innovative measures to improve the treatment for mental disorders. The main objective is to implement integrated healthcare networks based on evidence for effective treatment methods, deriving from high-quality research throughout five indications such as psychosis, depression, somatoform and functional syndromes, anorexia and bulimia and addiction illnesses in adolescence. Those networks are accompanied by additional measures, for example, for improving information and education, addressing occupational health or strengthening the participation of patients and their families suffering from mental illness. © 2012 Springer-Verlag.


PubMed | Montpellier University, Schon Klinik Hamburg Eilbek, University of the Sea, Panorama Medical Center and 5 more.
Type: Journal Article | Journal: Annals of the rheumatic diseases | Year: 2014

To evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission.GO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received add-on monthly 50-mg subcutaneous golimumab for 6months. The percentage of patients with good/moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)-erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28-ESR remission was measured.3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6years and mean DAS28-ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population.Add-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen.


Combe B.,Montpellier University | Dasgupta B.,University of the Sea | Louw I.,Panorama Medical Center | Pal S.,Advance Rheumatology Clinic | And 7 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: To evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite diseasemodifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission. Methods: GO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received addon monthly 50-mg subcutaneous golimumab for 6 months. The percentage of patients with good/ moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)- erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28-ESR remission was measured. Results: 3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6 years and mean DAS28-ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/ moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (∼25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population. Conclusions: Add-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen.


Kavanaugh A.,University of California at San Diego | Mease P.J.,Swedish Medical Center | Gomez-Reino J.J.,Hospital Clinico Universitario | Adebajo A.O.,University of Sheffield | And 9 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: Apremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy. Methods: In the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20% improvement in modified American College of Rheumatology response criteria (ACR20) at week 16. Results: At week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed. Conclusions: Apremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated.


Kavanaugh A.,University of California at San Diego | Mease P.J.,Swedish Medical Center | Gomez-Reino J.J.,Hospital Clinico Universitario | Adebajo A.O.,University of Sheffield | And 7 more authors.
Journal of Rheumatology | Year: 2015

Objective. To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, over 52 weeks in patients with active psoriatic arthritis (PsA) despite prior treatment. Methods. Patients were randomized to placebo (n = 168), apremilast 20 mg BID (n = 168), or apremilast 30 mg BID (n = 168). Patients whose swollen and tender joint counts had not improved by ≥ 20% at Week 16 were considered nonresponders and were required to be re-randomized (1:1) to apremilast 20 mg BID or 30 mg BID if they were initially randomized to placebo, or continued their initial treatment of apremilast dose. At Week 24, all remaining patients treated with placebo were re-randomized to apremilast 20 mg BID or 30 mg BID. Results. An American College of Rheumatology 20 (ACR20) response at Week 16 was attained by significantly more patients receiving apremilast 20 mg BID (30.4%, p = 0.0166) or 30 mg BID (38.1%, p = 0.0001) than placebo (19.0%). Among patients receiving apremilast continuously for 52 weeks (n = 254), ACR20 response at Week 52 was observed in 63.0% (75/119, 20 mg BID) and 54.6% (71/130, 30 mg BID) of patients. Response was also maintained across secondary outcomes, including measures of PsA signs and symptoms, skin psoriasis severity, and physical function. The nature, incidence, and severity of adverse events were comparable over the 24-week and 52-week periods. The most common adverse events, diarrhea and nausea, generally occurred early and were self-limited. Conclusion. Continuous apremilast treatment resulted in sustained improvements in PsA for up to 52 weeks. Apremilast had an acceptable safety profile and was generally well tolerated. Clinical trial registration: NCT01172938. The Journal of Rheumatology Copyright © 2015. All rights reserved.


Gerdes J.S.,Schon Klinik Hamburg Eilbek | Walther E.U.,Schon Klinik Hamburg Eilbek | Jaganjac S.,Schon Klinik Hamburg Eilbek | Makrigeorgi-Butera M.,MVZ Hanse Histologikum GmbH | And 2 more authors.
PLoS ONE | Year: 2014

Objective: We tested the hypothesis in sense of a proof of principle that white matter (WM) degeneration after cardiopulmonary arrest (CPA) can be assessed much earlier by diffusion tensor imaging (DTI) than by conventional MRI. Methods: We performed DTI and T2-weighted FLAIR imaging over four serial acquisitions of a 76-year-old man with unresponsive wakefulness syndrome at day 41, 75, 173 and 284 after CPA. DTI was also performed in ten healthy control subjects. Fractional anisotropy (FA) derived from DTI was assessed in eleven regions of interest within the cerebral white matter (WM) and compared with post-mortem neuropathological findings. Results: In contrast to conventional FLAIR images that revealed only circumscribed WM damage, the first DTI demonstrated significant reduction of FA across the whole WM. The following FLAIR images (MRI 2-4) revealed increasing atrophy and leukoaraiosis paralleled by clinical deterioration with reduction of wakefulness and intractable seizures. Neuropathological findings confirmed the widespread and marked brain injury following CPA. Conclusion: DTI may help to evaluate microstructural brain damage following CPA and may have predictive value for further evolution of cerebral degeneration in the chronic phase after CPA. © 2014 Gerdes et al.


PubMed | Anthropologenkontor and Schon Klinik Hamburg Eilbek
Type: | Journal: Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses | Year: 2016

To investigate differences in the acceptability between thickened and naturally viscous beverages.This was an exploratory, cross-sectional study.One hundred and twenty-eight healthy volunteers rated overall liking/disliking of a selection of each of three thickened drinks and three beverages of natural viscosity pre- and post consumption. Mean ratings were subjected to statistical analysis done with t tests.While all naturally thick beverages evoked good expectations, there were significant differences in expected acceptance of thickened fluids concerning the kind of beverage. Post consumption naturally thick beverages were rated significantly better than thickened.The findings suggest an alternative offer of naturally thick drinks and waiver of thickening water when viscosity adaption is needed.The sufficient and safe oral fluid intake in dysphagia requires compliance to dietetic recommendations. Naturally thick beverages can contribute to increase the appeal of texture-modified diet.


McInnes I.B.,University of Glasgow | Sieper J.,Rheumatology | Braun J.,Rheumazentrum Ruhrgebiet | Emery P.,University of Leeds | And 12 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objective: To evaluate the efficacy and safety of secukinumab, a fully human, anti-interleukin (IL)-17A monoclonal antibody, in patients with psoriatic arthritis (PsA). Methods: 42 patients with active PsA fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria were randomly assigned (2:1) to receive two intravenous secukinumab doses (10 mg/kg; n=28) or placebo (n=14) 3 weeks apart. The primary endpoint was the proportion of American College of Rheumatology (ACR) 20 responses at week 6 for secukinumab versus placebo (one-sided p<0.1). Results: Primary endpoint: ACR20 responses at week 6 were 39% (9/23) for secukinumab versus 23% (3/13) for placebo (p=0.27). ACR20 responses were greater with secukinumab versus placebo at week 12 (39% (9/23) vs 15% (2/13), p=0.13) and week 24 (43% (10/23) vs 18% (2/11), p= 0.14). At week 6, 'good' European League Against Rheumatism response was seen in 21.7% (5/23) secukinumab versus 9.1% (1/11) placebo patients. Compared with placebo at week 6, significant reductions were observed among secukinumab recipients for C reactive protein (p=0.039), erythrocyte sedimentation rate (p=0.038), Health Assessment Questionnaire Disability Index (p=0.002) and Short Form Health Survey (SF-36; p=0.030) scores. The overall adverse event (AE) frequency was comparable between secukinumab (26 (93%)) and placebo (11 (79%)) recipients. Six serious AEs (SAEs) were reported in four secukinumab patients and one SAE in one placebo patient. Conclusions: Although the primary endpoint was not met, clinical responses, acute-phase reactant and quality of life improvements were greater with secukinumab versus placebo, suggesting some clinical benefit. Secukinumab exhibited satisfactory safety. Larger clinical trials of secukinumab in PsA are warranted.


Beraldo S.,Schon Klinik Hamburg Eilbek | Neubeck K.,Schon Klinik Hamburg Eilbek | Von Friderici E.,Schon Klinik Hamburg Eilbek | Steinmuller L.,Schon Klinik Hamburg Eilbek
Scandinavian Journal of Surgery | Year: 2013

Background and Aims: The insertion of prophylactic ureteral stents in traditional colorectal surgery has been debated for a long time. The aim of this study is to investigate the results of ureteric stent insertion in elective laparoscopic colorectal surgery in terms of complications and costs. Material and Methods: From June 2009 to June 2011 one or two prophylactic ureteral stents were placed in all patients undergoing elective laparoscopic resection of their colon or rectum. Results: A total of 89 patients took part in this study, 61% had a benign disease and 39% malignant. The mean time for ureteral stent insertion was 16 min if one-sided and 21 min if bilateral. Incidental findings were found in the bladder in four (4.5%) patients. In all, 13 (26%) male patients had a benign prostatic adenoma, and 3 (6%) male patients had a significant stenosis of the urethral meatus and required bouginage. Complications due to ureteral stent insertion were transient hematuria in 11 (12.3%) cases, postoperative urinary tract infections in 2 (2.2%) cases, and hydronephrosis in 2 (2.2%) cases. One patient suffered an accidental damage of the right ureter despite the presence of a stent; this was recognized intraoperatively. The total cost for a one-sided ureteral stent insertion is calculated at around €360, and for a bilateral ureteral stent insertion, it is around €410. Conclusions: The prophylactic use of a ureteral stent in laparoscopic colorectal surgery leads to minor complications and may be cost-effective.


Jaganjac S.,Schon Klinik Hamburg Eilbek | Schefe L.,Schon Klinik Hamburg Eilbek
Vojnosanitetski Pregled | Year: 2015

Background/Aim. Palliative embolization of renal tumors is the method of choice in the treatment of advanced inoperable renal cell carcinoma in patients with hematuria and pain. Patients with small tumors in the remaining solitary kidney who refuse surgery are suitable for this type of therapy as well as patients with centrally located inoperable tumors. The prerequisite for successful capillary embolization is the closure of the main arterial trunk with metal spirals. Methods. In the period from 2000 to 2010 we conducted 42 palliative embolizations. The average age of the patients was 75 years, including 26 men and 16 women. In 8 of the patients the intervention was repeated and in one with severe AV shunts embolization was performed 4 times. Embolization was performed with alcohol, Ivalon 150–250 μm and with metal coils. Results. No serious complications were observed during and after the intervention. Fourteen patient were still alive then and among the deceased patients the average survival time was 13.5 ± 10.8 months with the range of 1 to 56 months. The minimal survival time was 1 month with a maximum survival time of 56 months. Conclusion. Our results are consistent with data in the literature. Survival in patients without metastases was longer than in those with metastases, as confirmed by the 14 of the patients from the study. An additional therapeutic safety in the treatment of small cancers is provided with a combination therapy of embolization and radiofrequency thermoablation. © 2015, Institut za Vojnomedicinske Naucne Informacije/Documentaciju. All rights reserved.

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